MAUDE Adverse Event Report: BLACK & BLACK SURGICAL BLACK & BLACK SURGICAL; RETRACTOR

Model Number	B61029
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility was contacted 4 times to receive the suspect devices for evaluation but the facility never sent the items back.The exact item number, lot, and full details of patient burn are unknown.If further information or device is received back, a follow up report will be issued.
Event or Problem Description
We were informed that during a procedure, a patient was burned with the fiberoptic retractor that was being used.

• Brand Name: BLACK & BLACK SURGICAL
• Common Device Name: RETRACTOR
• Manufacturer (Section D): BLACK & BLACK SURGICAL; 5175 south royal atlanta dr.; tucker GA 30084
• Manufacturer Contact: cynthia rees ; 5175 south royal atlanta dr.; tucker, GA 30084 ; 7704144880
• MDR Report Key: 23100260
• Report Number: 3006142527-2025-00001
• Device Sequence Number: 10142947
• Product Code: GAD
• UDI-Device Identifier: 00840329805425
• UDI-Public: 00840329805425
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: B61029
• Device Catalogue Number: B61029
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown